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Item Details
| Title:
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PROCESS VALIDATION FOR MANUFACTURING OF BIOLOGICS AND BIOTECHNOLOGY PRODUCTS
CONFERENCE, BERLIN, SEPTEMBER 2001, PROCEEDINGS |
| By: |
F. Brown (Editor), Anthony S. Lubiniecki (Editor) |
| Format: |
Paperback |
| List price:
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£68.50 |
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We currently do not stock this item, please contact the publisher directly for
further information.
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| ISBN 10: |
3805575769 |
| ISBN 13: |
9783805575768 |
| Publisher: |
S KARGER AG |
| Pub. date: |
18 September, 2003 |
| Series: |
Developments in Biologicals v. 113 |
| Pages: |
134 |
| Description: |
Regulatory documents and inspections have put increasing emphasis on process validation for all types of products, including biological and biotechnological ones. This volume portrays the expectations of the regulatory community and provides detailed examples of how various types of biological and biotechnological processes could be validated. |
| Synopsis: |
Regulatory documents and inspections have put increasing emphasis on process validation for all types of products, including biological and biotechnological ones. Until now, no description of a process validation for complex biological processes exists, let alone any concrete suggestion how to attain it: this book, however, attempts to fill the gap. Taking the current state of scientific practice in process validation as a starting point, this volume portrays the expectations of the regulatory community and provides detailed examples of how various types of biological and biotechnological processes could be validated. Considering the sizeable difficulties in designing a single method of process validation suitable for all types of processes and products, the authors discuss the implications and present many possible routes to a successful validation process. |
| Illustrations: |
16, 16 fig., 20 tab. |
| Publication: |
Switzerland |
| Imprint: |
S Karger AG |
| Returns: |
Non-returnable |
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